Agency Information Collection Activities: Proposed Collection; Comment Request, 2952-2953 [2015-00843]
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Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices
for treatment of neuropsychiatric
indications.
DATES: Only written comments and/or
applications for a license that are
received by the NIH Office of
Technology Transfer on or before
February 5, 2015 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated Start-Up Exclusive license
should be directed to: Susan Ano, Ph.D.,
Branch Chief, Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville, MD 20852–3804; Telephone:
(301) 435–5515; Facsimile: (301) 402–
0220; Email: anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
The subject invention describes the
use of scopolamine for the treatment of
depression, including major depressive
disorder. Scopolamine is a known
compound that has been employed in
the treatment of nausea and motion
sickness, as well as in conjunction with
analgesics but the suitability of
scopolamine for treating depression was
unrecognized prior to this invention.
An important feature of scopolamine,
as a treatment for depression, is its fastacting nature. Currently available
treatments can be ineffective in certain
depression patients and typically do not
show an effect in any patient until four
weeks after first administration.
However, preclinical data suggests that
scopolamine has a rapid, wide-ranging
and long lasting effect. This feature
makes scopolamine highly desirable as
a new treatment for depression.
The prospective Start-Up Exclusive
License Agreement is being considered
under the small business initiative
launched on October 1, 2011 and
complies with the terms and conditions
of 35 U.S.C. 209 and 37 CFR 404. The
prospective exclusive license may be
granted unless within fifteen (15) days
from the date of this published notice,
the NIH receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR 404. Complete applications
for a license in the prospective field of
use that are filed in response to this
notice will be treated as objections to
the grant of the contemplated Start-Up
Exclusive Patent License. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: January 13, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology
Transfer, National Institutes of Health.
[FR Doc. 2015–00811 Filed 1–20–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Substance Abuse and
Mental Health Data Archive (SAMHDA)
Data Portal Applications—In Use
Without Approval
The Substance Abuse and Mental
Health Administration (SAMHSA),
Center for Behavioral Health Statistics
and Quality (CBHSQ) funded the
SAMHDA contract to promote the
access and use of the nation’s substance
abuse and mental health data on
December 3rd, 1997. This includes
public-use data files, file
documentation, and access to restricteduse data files to support a better
understanding of this critical area of
public health. As a part of the SAMHDA
initiative, the Data Portal was created
and launched in January of 2013. The
Data Portal provides researchers that
need access to restricted-use data
remote access to confidential data via a
virtual desktop from a secure, approved
location. Completions of an application
process and project approval are
required for Data Portal access. The
information being collected in this
needs assessment will provide CBHSQ
the information required to determine
whether a researcher is qualified to
obtain access to the Data Portal, and
restricted-use data collected under the
Confidential Information Protection and
Statistical Efficiency Act (CIPSEA).
Description of Forms: Applications
will include 18 questions and require
the submission of CV’s. The application
asks for information including the name
of the organization that the researcher
belongs to, name, title and contact
information of the researcher and all
subsequent researchers on the team,
summaries of each applicants
experience with restricted data and their
CV’s, descriptions of the proposed
research projects and methodology,
what data is being requested and why,
and any potential restricted variables
that may be requested.
Description of Respondents: The
respondent universe for this data
collection effort is researchers with a
need for access to CBHSQ restricted-use
data. These data include the National
Survey on Drug Use and Health
(NSDUH), the Drug Abuse Warning
Network (DAWN), and NSDUH/DAWN
supplement data. Respondents are
researchers that have a need and want
to provide this information. There are
open calls for applications that occur 2
times a year, and applications are
accepted during a month long period.
Anyone may apply.
TABLE 1—ANNUAL BURDEN ESTIMATE
Form name
Number of
respondents
Annual
responses per
respondent
Total annual
responses
Hours per
response
Total annual
hour burden
Data Portal Application Needs Assessment ........................
100
1
100
5
500
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Federal Register / Vol. 80, No. 13 / Wednesday, January 21, 2015 / Notices
Send comments to Summer King,
SAMHSA Reports Clearance Officer,
Room 2–1057, One Choke Cherry Road,
Rockville, MD 20857 or email her a
copy at summer.king@samhsa.hhs.gov.
Written comments should be received
by March 23, 2015.
Summer King,
Statistician.
[FR Doc. 2015–00843 Filed 1–20–15; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
asabaliauskas on DSK5VPTVN1PROD with NOTICES
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
VerDate Sep<11>2014
17:50 Jan 20, 2015
Jkt 235001
Proposed Project: National Evaluation
of the Comprehensive Community
Mental Health Services for Children
and Their Families Program: Phase VI
(OMB No. 0930–0307)—Revision
The Substance Abuse and Mental
Health Services Administration
(SAMHSA), Center of Mental Health
Services is responsible for the national
evaluation of the Comprehensive
Community Mental Health Services for
Children and Their Families Program
(Children’s Mental Health Initiative—
CMHI) that will collect data on child
mental health outcomes, family life, and
service system development. Data will
be collected on nine (9) service systems,
and approximately 2,106 children and
families and providers/administrators,
using 26 instruments. Data collection
will be decreased by 26,960 hours due
to program changes resulting from the
closing of 19 communities funded in FY
2009 that no longer require data
collection and data collection for the
Sector and Comparison Study.
Data collection for this evaluation will
be conducted over the next 3-year
period. Child and family outcomes of
interest will be collected at intake and
at 6-month follow-up. The individual
families will participate in the study for
the remaining 12 months. The outcome
measures include the following: Child
symptomatology and functioning,
family functioning, satisfaction, and
caregiver strain. The service system data
will be collected every 6 months during
the remaining 3 years of the evaluation.
Service utilization and cost data will be
tracked and submitted to the national
evaluation every 6 months using two
tools—the Flex Fund Tool and the
Services and Costs Data Tool—to
estimate average cost of treatment per
child, distribution of costs, and
allocation of costs across service
categories. Service delivery and system
variables of interest include the
following: Maturity of system of care
development in funded system of care
communities, adherence to the system
of care program model, and client
service experience. Internet-based
technology such as data entry and
management tools will be used in this
evaluation. The measures of the national
evaluation address annual
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Congressional reporting requirements of
the program’s authorizing legislation,
and the national outcome measures for
mental health programs as currently
established by SAMHSA.
Changes:
The previously approved Phase VI
evaluation is composed of six core study
components: (1) The System of Care
Assessment that documents the
development of systems of care through
site visits conducted every 12–18
months; (2) the Cross-Sectional
Descriptive Study that collects
descriptive data on all children and
families who enter the CMHS-funded
systems of care throughout the funding
period; (3) the Child and Family
Outcome Study that collects data
longitudinally on child clinical and
functional status, and family outcomes;
(4) the Service Experience Study that
collects data on family experience and
satisfaction with services from a sample
of children and families; (5) the Services
and Costs Study that assesses the costs
and cost-effectiveness of system of care
services; and (6) the Sustainability
Study, as well as and three special
studies: the Alumni Networking Study,
the Continuous Quality Improvement
(CQI) Initiative Evaluation, and the
Sector and Comparison Study. Earlier
revisions eliminated one of the core
studies, the Sustainability Study, and
two of the special studies: the Alumni
Networking Study and the Continuous
Quality Improvement (CQI) Initiative
Evaluation.
This revision requests the elimination
of the Sector and Comparison Study.
The eliminated studies have provided
data to the program and are no longer
needed. The Sector and Comparison
Study was conducted with a subsample
of the FY 2008-funded CA awardees,
which are not included in this revision.
The average annual respondent
burden is estimated below. The estimate
reflects the average number of
respondents in each respondent
category, the average number of
responses per respondent per year, the
average length of time it will take to
complete each response, and the total
average annual burden for each category
of respondent, and for all categories of
respondents combined.
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]]>Agencies
[Federal Register Volume 80, Number 13 (Wednesday, January 21, 2015)]
[Notices]
[Pages 2952-2953]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00843]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection;
Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995 concerning opportunity for public comment on proposed
collections of information, the Substance Abuse and Mental Health
Services Administration (SAMHSA) will publish periodic summaries of
proposed projects. To request more information on the proposed projects
or to obtain a copy of the information collection plans, call the
SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of
information are necessary for the proper performance of the functions
of the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology.
Proposed Project: Substance Abuse and Mental Health Data Archive
(SAMHDA) Data Portal Applications--In Use Without Approval
The Substance Abuse and Mental Health Administration (SAMHSA),
Center for Behavioral Health Statistics and Quality (CBHSQ) funded the
SAMHDA contract to promote the access and use of the nation's substance
abuse and mental health data on December 3rd, 1997. This includes
public-use data files, file documentation, and access to restricted-use
data files to support a better understanding of this critical area of
public health. As a part of the SAMHDA initiative, the Data Portal was
created and launched in January of 2013. The Data Portal provides
researchers that need access to restricted-use data remote access to
confidential data via a virtual desktop from a secure, approved
location. Completions of an application process and project approval
are required for Data Portal access. The information being collected in
this needs assessment will provide CBHSQ the information required to
determine whether a researcher is qualified to obtain access to the
Data Portal, and restricted-use data collected under the Confidential
Information Protection and Statistical Efficiency Act (CIPSEA).
Description of Forms: Applications will include 18 questions and
require the submission of CV's. The application asks for information
including the name of the organization that the researcher belongs to,
name, title and contact information of the researcher and all
subsequent researchers on the team, summaries of each applicants
experience with restricted data and their CV's, descriptions of the
proposed research projects and methodology, what data is being
requested and why, and any potential restricted variables that may be
requested.
Description of Respondents: The respondent universe for this data
collection effort is researchers with a need for access to CBHSQ
restricted-use data. These data include the National Survey on Drug Use
and Health (NSDUH), the Drug Abuse Warning Network (DAWN), and NSDUH/
DAWN supplement data. Respondents are researchers that have a need and
want to provide this information. There are open calls for applications
that occur 2 times a year, and applications are accepted during a month
long period. Anyone may apply.
Table 1--Annual Burden Estimate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Form name Number of responses per Total annual Hours per Total annual
respondents respondent responses response hour burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Portal Application Needs Assessment........................... 100 1 100 5 500
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 2953]]
Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 2-1057, One Choke Cherry Road, Rockville, MD 20857 or email her a
copy at summer.king@samhsa.hhs.gov. Written comments should be received
by March 23, 2015.
Summer King,
Statistician.
[FR Doc. 2015-00843 Filed 1-20-15; 8:45 am]
BILLING CODE 4162-20-P
